September 29, 2020

The Niche

Knoepfler lab stem cell blog

Clinics can’t retract stem cell treatments gone bad

Stem cell facelift comicYou can stop taking a pill or an injection treatment, but you can’t stop or retract stem cell treatments if there’s a bad side effect.

Unlike other kinds of medicines, once stem cells have been transplanted into patients, if something goes wrong you cannot stop the ‘treatment’. There’s no retraction possible because transplanted stem cells spread in the body and potentially integrate.

One of the striking things in the commercial stem cell arena in 2016 was the emergence of patient lawsuits against stem cell clinics including two proposed class action suits. These patients, and I count potentially now more than a dozen, allege a variety of harms ranging from tumors to blindness. The reason I mention this is that there appears to be huge potential for harm to patients from unapproved stem cell therapies. I know a lot of patients who would wish they could undo what the stem cell clinic did. It’s just not possible.Stem cell cartoon

Even in an appropriately regulated stem cell trial context, there’s no easy way to undo stem cell transplants. There has been talk for years about suicide genes to be inserted into stem cells to provide “a net” should something go awry with stem cell treatments, but it’s not clear how well these would work and stem cell clinics aren’t interested in that anyway.

The fact that stem cell treatments cannot be retracted to try to help patients who end up in dire straits because of the experimental therapy means there’s even greater reason why proper oversight is needed. Stem cells are not some universal healing clay with miraculous powers that any doc anywhere can pick up and use in patients with all kinds of health problems.

Doctors should receive extensive training in stem cells (no, a weekend golf course seminar on stem cells doesn’t count) and in bioethics, and they should be in contact with the FDA before injecting even one patient. Doctors should also not try to treat patients with stem cells when the patients have maladies outside the doctor’s area of specialty. There’s nothing magic about stem cells that, for instance, suddenly allows a plastic or orthopedic surgeon or dermatologist to ethically and safely treat patients with conditions outside their expertise like neurological or respiratory problems.

Stem cells are not Starbucks coffee or McDonalds hamburgers that can be safely franchised across the country. Patients shouldn’t be treated like drive-thru customers.

What the recent flurry of stem cell lawsuits also illustrate is that some doctors are putting their practices at grave risk and once you screw up with one or a few patients, again you cannot retract the stem cell treatments. You may have permanently hurt the patients. You’re also likely going to end up in court or making a multi-million-dollar settlement that makes your malpractice insurer very unhappy with you. You could end up in the newspaper too and not in a good way.

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